Melatonin and Sleep Spindles in Autism

Massachusetts General Hospital (Other)
Overall Status
Recruiting ID

Study Details

Study Description

Brief Summary

Sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. We hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. This communication is mediated by the thalamic reticular nucleus (TRN). Due to its small size and location deep in the brain, we cannot assess TRN function without invasive techniques. Fortunately, sleep spindles, a specific brain rhythm provide a noninvasive read-out of TRN function. In Aim 1 we will examine whether reduced sleep spindles are related to worse sleep quality, impaired selective attention during wake, and sensory sensitivities in children with autism. In Aim 2, we will determine whether melatonin, which is commonly used to improve sleep, also increases sleep spindles in autism. If successful, this study will introduce TRN as a target for treatment of sleep disruption and guide larger home-based sleep studies.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Melatonin

Study Design

Study Type:
Anticipated Enrollment :
30 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effects of Melatonin on Sleep Spindles in Children With Autism
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Melatonin

5mg melatonin gummy 30 min before bedtime for 2 consecutive nights

Dietary Supplement: Melatonin
5mg gummy 30 min before bedtime for 2 consecutive nights

Outcome Measures

Primary Outcome Measures

  1. Change in sleep spindle density [Five nights of sleep over two weeks]

    Changes in sleep spindle density (#/min) during non-Rapid Eye Movement (NREM) sleep between baseline and melatonin nights as measured by portable EEG device.

Secondary Outcome Measures

  1. Change in sleep quality [Five nights of sleep over two weeks]

    Change in sleep quality between baseline and melatonin nights

Eligibility Criteria


Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Male and female subjects with ASD

  • 12-18 years of age

  • English speaking

  • Able to understand and respond to questionnaires in English

Exclusion Criteria:
  • Pregnant or breastfeeding

  • Substance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary)

  • Chronic medical conditions that affect sleep

  • Any unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease

  • History of head injury resulting in prolonged loss of consciousness or other neurological sequelae

  • IQ <70

  • Other neurological disorder, including seizure disorder

  • Diagnosed sleep disorder

  • Known genetic causes of ASD

  • Currently taking melatonin or those who have had an adverse reaction to melatonin in the past

Contacts and Locations


Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital


  • Principal Investigator: Dara Manoach, PhD, Professor

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Dara S. Manoach, PhD, Professor, Massachusetts General Hospital Identifier:
Other Study ID Numbers:
  • 2021P002832
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 10, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Dara S. Manoach, PhD, Professor, Massachusetts General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2023